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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05872490
Other study ID # GA-2021-06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 5, 2019
Est. completion date March 1, 2022

Study information

Verified date July 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to learn about predictors associated with maintaining driving in old age. The main questions it aims to answer are : - which and how medical factors can influence stopping or maintaining driving (quantitative research) - how social environment can influence stopping or maintaining driving (quantitative research) - what are the needs of all the actors in the field (qualitative research) - know about the opinions and practices of all the actors in the field (qualitative research) Participants will be ask to answer questions in an interview taking about an hour. Quantitative research will ask participants to fill out a questionnaire about social environment.


Description:

FAMACO is a project led by Gérontopôle Auvergne Rhône-Alpes (AURA) and Chaire Santé des Ainés of the Jean Monet University, supported by the Observatoire National Interministériel de la Sécurité Routière (ONISR), that aims prevent the loss of autonomy of the elderly population by identifying predictors associated with maintaining driving in old age. This is a mixed quantitative and qualitative prospective study. Quantitative study identify medical factors linked to stopping driving by analysis data from "PROnostic of factors OF cardiovascular or neurovascular disease" (PROOF) cohort. In addition, a questionnaire on the social environment was addressed to participants. Qualitative study focus on identifying the expectations and needs of all concern populations : elderly divers, elderly former drivers, general practitioner, geriatrician, certified driver's license physician, law enforcement, driving instructors and emergency services. This qualitative study will be carried out on three different sites : Saint-Etienne, Marseille, and Lille.


Recruitment information / eligibility

Status Completed
Enrollment 657
Est. completion date March 1, 2022
Est. primary completion date March 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria : - being part of one of the population studied (older 65 people ; attending physicians ; law enforcement ; certified driver's license ; physicians ; geriatricians ; driving instructors ; personal assistance services) - live in Saint-Etienne, Marseille or Lille Exclusion criteria : None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Semi-structured interviews
An interview guide was developed for each population. Depending on the population interviewed, this interview guide focuses on the current state of driving, the obstacles and levers to driving, the representations related to driving by the elderly, their opinion concerning the implementation of a potential aptitude test and more generally their opinion on policies related to road safety.
Questionnaire
The questionnaire asks people aged 80 and over included in the PROOF cohort about their relationship to driving, their driving status, their societal and personal environment, the circumstances in which they stopped driving, recent accidents and, more generally, their driving habits.

Locations

Country Name City State
France François Puisieux Lille
France Sylvie Bonin-Guillaume Marseille
France Nathalie Barth Saint-Étienne Loire

Sponsors (5)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne Centre de Recherche Hospitalier Universitaire de Marseille, Gerontopole Auvergne Rhone-Alpes (AURA), Université Jean Monnet de Saint-Etienne, University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Views and representations of the different populations on the conduct of the elderly Representations and habits of elderly driving were study by individual semi-directive interviews. The aims is to identify, in the accounts of experiences, the practices, the relationship to driving and to other forms of transport, the lived experience, the representations of driving and ageing. Day 1
Secondary Driving habits of elderly Habits of elderly driving were study by a questionnaire to understand the social and personal environment in relation to driving habits.
The Evaluation of Precariousness and health Inequalities in health Examination Centers Score (EPICES score) was measured in this questionnaire. This individual indicator allows for the measurement of precariousness by taking into account its multidimensional nature.The questionnaire is composed of 11 questions which summarise 90% of the precariousness situation of a subject. Each question is assigned a coefficient and the sum of the answers gives the score. The score is continuous and varies from 0 (no insecurity) to 100 (maximum insecurity). The threshold of 30 is considered as the threshold of precariousness.
Day 1
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